Amgen July weekly volatility elevated into Q2 and outlook Amgen July weekly call option implied volatility is at 61, August is at 32, September is at 29; compared to its 52-week range of 18 to 34, suggesting large near term price movement into the expected release of Q2 results on July 30.

Radius Health hires Dr. Lorraine Fitzpatrick as Chief Medical Officer Radius Health (RDUS) announced that it has hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of the Company. Dr. Fitzpatrick was previously Medicine Development Leader of an international clinical development team for Denosumab at GlaxoSmithKline (GSK), responsible for clinical development, regulatory, manufacturing, commercial, operations, epidemiology, and global health outcomes. Previously, Dr. Fitzpatrick led the clinical development of novel agents to treat musculoskeletal diseases and women's health at GlaxoSmithKline. Before joining GlaxoSmithKline, Dr. Fitzpatrick was Executive Director at Amgen, Inc. where she worked in the fields of osteoporosis and oncology.

NephroGenex names Jaikrishna Patel as Chief Medical OfficerNephroGenex (NRX) announced the appointment of Dr. Jaikrishna Patel to the position of Chief Medical Officer. Dr. Patel will help guide the company’s Phase 3 PIONEER program with oral Pyridorin for the treatment of diabetic nephropathy, and the development of an intravenous formulation of Pyridorin for acute kidney injury. Patel has held numerous positions of increasing responsibility at GlaxoSmithKline (GSK) and its predecessor companies, most recently serving as Vice President of Cardiovascular and Cardiovascular Metabolism, Global Regulatory Affairs.

FDA approves expanded use of Kyprolis in multiple myeloma patientsThe FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link

Amgen submits NDA for Kyprolis in relapsed multiple myelomaAmgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.

Piper confident in Regeneron approval by FridayAfter Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.

Amgen's Repatha granted marketing authorization by ECAmgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.